Drugs@FDA: FDA Approved Drug Products
Abbreviated New Drug Application (ANDA): 091687
Company: TRIS PHARMA INC
Company: TRIS PHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | 15MG/5ML;6.25MG/5ML | SYRUP;ORAL | Discontinued | None | No | No |
| PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | PROMETHAZINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE | 15MG/5ML | TABLET, CHEWABLE, TABLET, CAPSULE; ORAL | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 06/28/2012 | ORIG-1 | Approval | Not Applicable |
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